Spine distraction implant and method

ABSTRACT

A spine distraction implant alleviates pain associated with spinal stenosis and facet arthropathy by expanding the volume in the spine canal and/or neural foramen. The implant provides a spinal extension stop while allowing freedom of spinal flexion.

BACKGROUND OF THE INVENTION

[0001] As the present society ages, it is anticipated that there will bean increase in adverse spinal conditions which are characteristic ofolder people. By way of example, with aging comes increases in spinalstenosis (including but not limited to central canal and lateralstenosis), the thickening of the bones which make up the spinal columnand facet arthropathy. Spinal stenosis is characterized by a reductionin the available space for the passage of blood vessels and nerves. Painassociated with such stenosis can be relieved by medication and/orsurgery. Of course, it is desirable to eliminate the need for majorsurgery for all individuals and in particular for the elderly.

[0002] Accordingly, there needs to be developed procedures and implantsfor alleviating such condition which are minimally invasive, can betolerated by the elderly and can be performed preferably on anoutpatient basis.

SUMMARY OF THE INVENTION

[0003] The present invention is directed to providing a minimallyinvasive implant and method for alleviating discomfort associated withthe spinal column.

[0004] The present invention provides for apparatus and method forrelieving pain by relieving the pressure and restrictions on theaforementioned blood vessels and nerves. Such alleviation of pressure isaccomplished in the present invention through the use of an implant andmethod which distract the spinous process of adjacent vertebra in orderto alleviate the problems caused by spinal stenosis and facetarthropathy and the like. While the implant and method particularlyaddress the needs of the elderly, the invention can be used withindividuals of all ages and sizes where distraction of the spinousprocess would be beneficial.

[0005] In one aspect of the invention, an implant is provided forrelieving pain comprising a device positioned between a first spinousprocess and a second spinous process. The device includes a spinalcolumn extension stop and a spinal column flexion non-inhibitor.

[0006] In another aspect of the invention, the implant is positionedbetween the first spinous process and the second spinous process andincludes a distraction wedge that can distract the first and secondspinous processes as the implant is positioned between the spinousprocesses.

[0007] In yet another aspect of the present invention, the implantincludes a device which is adapted to increasing the volume of thespinal canal and/or the neural foramen as the device is positionedbetween adjacent spinous processes.

[0008] In yet a further aspect of the present invention, a method ispresented for relieving pain due to the development of, by way ofexample only, spinal stenosis and facet arthropathy. The method iscomprised of the steps of accessing adjacent first and second spinalprocesses of the spinal column and distracting the processes asufficient amount in order to increase the volume of the spinal canal inorder to relieve pain. The method further includes implanting a devicein order to maintain the amount of distraction required to relieve suchpain.

[0009] In yet a further aspect of the invention, the method includesimplanting a device in order to achieve the desired distraction and tomaintain that distraction.

[0010] In yet a further aspect of the invention, the implant includes afirst portion and a second portion. The portions are urged together inorder to achieve the desired distraction.

[0011] Other implants and methods within the spirit and scope of theinvention can be used to increase the volume of the spinal canal therebyalleviating restrictions on vessels and nerves associated therewith, andpain.

BRIEF DESCRIPTION OF THE FIGURES

[0012]FIGS. 1 and 2 depict an embodiment of an implant of the inventionwhich is adjustable in order to select the amount of distractionrequired. FIG. 1 depicts the implant in a more extended configurationthan does FIG. 2.

[0013]FIGS. 3a and 3 b depict side and end views of a first forked andof the embodiment of FIG. 1.

[0014]FIGS. 4a and 4 b depict side sectioned and end views of aninterbody piece of the implant of FIG. 1.

[0015]FIGS. 5a and 5 b depict side and end views of a second forked endof the embodiment of FIG. 1.

[0016]FIGS. 6, 7, 8, 9 and 10 depict apparatus and method for anotherembodiment of the present invention for creating distraction betweenadjacent spinous processes.

[0017]FIGS. 11, 12 and 13 depict yet a further embodiment of theinvention for creating distraction between adjacent spinous processes.

[0018]FIGS. 14 and 15 depict a further apparatus and method of anembodiment of the invention for creating distraction.

[0019]FIGS. 16, 16a, and 17 depict yet another embodiment of the presentinvention.

[0020]FIGS. 18, 19 and 20 depict yet a further apparatus and method ofthe present embodiment.

[0021]FIGS. 21 and 22 depict still a further embodiment of the presentinvention.

[0022]FIGS. 23, 24 and 25 depict another embodiment of the presentinvention.

[0023]FIGS. 26, 27 and 28 depict another embodiment of the invention.

[0024]FIGS. 29 and 30 depict side elevational views of differentlyshaped implants of embodiments of the present invention.

[0025]FIGS. 31, 32 and 33 depict various implant positions of anapparatus of the present invention.

[0026]FIGS. 34 and 35 depict yet another apparatus and method of thepresent invention.

[0027]FIGS. 36, 37 and 38 depict three different embodiments of thepresent invention.

[0028]FIGS. 39 and 40 depict yet another apparatus and method of anembodiment of the present invention.

[0029]FIGS. 41, 42 and 43 depict yet further embodiments of an apparatusand method of the present invention.

[0030]FIG. 44 is still a further embodiment of an implant of theinvention.

[0031]FIG. 45 is yet another depiction of an apparatus and method of theinvention.

[0032]FIGS. 46 and 47 depict still a further apparatus and method of anembodiment of the invention.

[0033]FIGS. 48, 49, 50 and 51 depict yet a further apparatus and methodof the invention.

[0034]FIGS. 52, 53, 54, 55 a and 55 b depict another apparatus andmethod of the invention.

[0035]FIGS. 56, 57 and 58 depict yet a further apparatus and method ofthe invention.

[0036]FIGS. 59 and 60 depict still a further embodiment of theinvention.

[0037]FIG. 61 depict another embodiment of the invention.

[0038]FIGS. 62 and 63 depict yet another embodiment of the presentinvention.

[0039]FIGS. 64 and 65 depict still a further embodiment of the presentinvention.

[0040]FIG. 66 depicts another embodiment of the invention.

[0041]FIGS. 67 and 68 depict yet another embodiment of the presentinvention.

[0042]FIGS. 69, 70, 71 and 71 a depict a further embodiment of thepresent invention.

[0043]FIGS. 72 and 73 depict still another embodiment of the invention.

[0044]FIGS. 74, 75, 76, 77, and 78 depict still other embodiments of theinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Embodiment of FIGS. 1-5a, 5 b

[0045] A first embodiment of the invention is shown in FIGS. 1-5 a, 5 b.Implant 20 includes first and second forked ends 22 and 24, eachdefining a saddle 26, 28 respectively. The forked ends 22, 24 are matedusing an interbody piece 30. As can be seen in FIGS. 3a, 3 b, the firstforked end 22 includes a threaded shaft 32 which projects rearwardlyfrom the saddle 26. The threaded shaft 32 fits into the threaded bore 34(FIG. 4a) of the interbody piece 30.

[0046] The second forked end 24 (FIGS. 5a, 5 b) includes a smoothcylindrical shaft 36 which can fit into the smooth bore 38 of theinterbody piece 30.

[0047]FIG. 1 shows the implant 20 in a fully extended position, whileFIG. 2 shows the implant in an unextended position. In the unextendedposition, it can be seen that the threaded shaft 32 of the first forkedend 22 fits inside the hollow cylindrical shaft 36 of the second forkedend 24.

[0048] For purposes of implantation between adjacent first and secondspinous processes of the spinal column, the implant 20 is configured asshown in FIG. 2. The first and second spinous processes are exposedusing appropriate surgical techniques and thereafter, the implant 20 ispositioned so that saddle 26 engages the first spinous process, andsaddle 28 engages the second spinous process. At this point, theinterbody piece 30 can be rotated by placing an appropriate tool or pininto the cross holes 40 and upon rotation, the saddle 26 is movedrelative to the saddle 28. Such rotation spreads apart or distracts thespinous processes with the resultant and beneficial effect of enlargingthe volume of the spinal canal in order to alleviate any restrictions onblood vessels and nerves.

[0049] It is noted that this implant as well as the several otherimplants described herein act as an extension stop. That means that asthe back is bent backwardly and thereby placed in extension the spacingbetween adjacent spinous processes cannot be reduced to a distance lessthan the distance between the lowest point of saddle 26 and the lowestpoint of saddle 28. This implant, however, does not inhibit or in anyway limit the flexion of the spinal column, wherein the spinal column isbent forward.

[0050] Preferably, such a device provides for distraction in the rangeof about 5 millimeters to about 15 millimeters. However, devices whichcan distract up to and above 22 millimeters may be used depending on thecharacteristics of the individual patient.

[0051] With all the ligaments (such as the superspinous ligament) andtissues associated with the spinous processes left intact, the implant20 can be implanted essentially floating in position in order to gainthe benefits of the aforementioned extension stop and flexionnon-inhibitor. If desired, one of the saddles 26 can be laterally pinnedwith pin 29 to one of the spinous processes and the other saddle can beloosely associated with the other spinous processes by using a tether 31which either pierces or surrounds the other spinous process and then isattached to the saddle in order to position the saddle relative to thespinous process. Alternatively, both saddles can be loosely tethered tothe adjacent spinous process in order to allow the saddles to moverelative to the spinous processes.

[0052] The shape of the saddles, being concave, gives the advantage ofdistributing the forces between the saddle and the respective spinousprocess. This ensures that the bone is not resorbed due to the placementof the implant 20 and that the structural integrity of the bone ismaintained.

[0053] The implant 20 in this embodiment can be made of a number ofmaterials, including but not limited to, stainless steel, titanium,ceramics, plastics, elastics, composite materials or any combination ofthe above. In addition, the modulus of elasticity of the implant can bematched to that of bone, so that the implant 20 is not too rigid. Theflexibility of the implant can further be enhanced by providingadditional apertures or perforations throughout the implant in additionto the holes 40 which also have the above stated purpose of allowing theinterbody piece 30 to be rotated in order to expand the distance betweenthe saddle 26, 28.

[0054] In the present embodiment, it is understood that the spinousprocesses can be accessed and distracted initially using appropriateinstrumentation, and that the implant 20 can be inserted and adjusted inorder to maintain and achieve the desired distraction. Alternatively,the spinous process can be accessed and the implant 20 appropriatelypositioned. Once positioned, the length of the implant can be adjustedin order to distract the spinous processes or extend the distraction ofalready distracted spinous processes. Thus, the implant can be used tocreate a distraction or to maintain a distraction which has already beencreated.

[0055] The placement of implants such as implant 20 relative to thespinous process will be discussed hereinbelow with other embodiments.However, it is to be noted that ideally, the implant 20 would be placedclose to the instantaneous axis of rotation of the spinal column so thatthe forces placed on the implant 20 and the forces that the implant 20places on the spinal column are minimized.

[0056] Further, it is noted that during the actual process of installingor implanting the implant 20, that the method uses the approach ofextending the length of the implant 20 a first amount and then allowingthe spine to creep or adjust to this distraction. Thereafter, implant 20would be lengthened another amount, followed by a period where the spineis allowed to creep or adjust to this new level of distraction. Thisprocess could be repeated until the desired amount of distraction hasbeen accomplished. This same method can be used with insertion toolsprior to the installation of an implant. The tools can be used to obtainthe desired distraction using a series of spinal distraction and spinecreep periods before an implant is installed.

Embodiment of FIGS. 6, 7, 8, 9 and 10

[0057] The embodiment of the invention shown in the above FIGS. 6, 7, 8,9 and 10 includes distraction or spreader tool 50 which has first andsecond arms 52, 54. Arms 52, 54 are pivotal about pivot point 56 andreleaseable from pivot point 56 in order to effect the implantation ofimplant 58. As can be seen in FIG. 6, in cross-section, the arms 52, 54are somewhat concave in order to cradle and securely hold the firstspinous process 60 relative to arm 52 and the second spinous process 62relative to arm 54. The distraction tool 50 can be inserted through asmall incision in the back of the patient in order to address the spacebetween the first spinous process 60 and the second spinous process 62.Once the tool 50 is appropriately positioned, the arms 52, 54 can bespread apart in order to distract the spinous processes. After this hasoccurred, an implant 58 as shown in FIGS. 8 and 9, or of a design shownin other of the embodiments of this invention, can be urged between thearms 52, 54 and into position between the spinous processes. After thisoccurs, the arms 52, 54 can be withdrawn from the spinous processesleaving the implant 58 in place. The implant 58 is urged into placeusing a tool 64 which can be secured to the implant 58 through athreaded bore 66 in the back of the implant. As can be seen in FIG. 10,the implant 58 includes saddles 68 and 70 which cradle the upper andlower spinous processes 60, 62 in much the same manner as the abovefirst embodiment and also in much the same manner as the individual armsof the tool 50. The saddles as described above tend to distribute theload between the implant and the spinous processes and also assure thatthe spinous process is stably seated at the lowest point of therespective saddles.

Embodiment of FIGS. 11, 12 and 13

[0058] Another embodiment of the apparatus and method of the inventionis shown in FIGS. 11, 12 and 13. In this embodiment, the spreader ordistraction tool 80 includes first and second arms 82, 84 which arepermanently pivoted at pivot point 86. The arms include L-shaped ends88, 90. Through a small incision, the L-shaped ends 88, 90 can beinserted between the first and second spinous processes 92, 94. Oncepositioned, the arms 82, 84 can be spread apart in order to distract thespinous processes. The implant 96 can then be urged between the spinousprocesses in order to maintain the distraction. It is noted that implant96 includes wedged surfaces or ramps 98, 100. As the implant 96 is beingurged between the spinous processes, the ramps further cause the spinousprocesses to be distracted. Once the implant 96 is fully implanted, thefull distraction is maintained by the planar surfaces 99, 101 locatedrearwardly of the ramps. It is to be understood that the cross-sectionof the implant 96 can be similar to that shown for implant 58 or similarto other implants in order to gain the advantages of load distributionand stability.

Embodiments of FIGS. 14, 15, 16, 16 a, and 17

[0059] In FIGS. 14 and 15, yet another embodiment of the invention isdepicted. In this embodiment, the implant 110 includes first and secondconically shaped members 112, 114. Member 112 includes a male snapconnector 116 and member 114 includes a female snap connector 118. Withmale snap connector 116 urged into female snap connector 118, the firstmember 112 is locked to the second member 114. In this embodiment, adistraction or spreader tool 80 could be used. Once the spinous processhas been spread apart, an implantation tool 120 can be used to positionand snap together the implant 1 10. The first member 112 of implant 110is mounted on one arm and second member 114 is mounted on the other armof tool 120. The member 112, 114 are placed on opposite sides of thespace between adjacent spinous processes. The members 112, 114 are urgedtogether so that the implant 110 is locked in place between the spinousprocesses as shown in FIG. 15. It is to be noted that the implant 110can also be made more self-distracting by causing the cylindricalsurface 122 to be more conical, much as surface 124 is conical, in orderto hold implant 110 in place relative to the spinous processes and alsoto create additional distraction.

[0060] An alternative embodiment of the implant can be seen in FIGS. 16and 17. This implant 130 includes first and second members 132, 134. Inthis particular embodiment, the implants are held together using a screw(not shown) which is inserted through countersunk bore 136 and engages athreaded bore 138 of the second member 134. Surfaces 139 are flattened(FIG. 17) in order to carry and spread the load applied thereto by thespinous processes.

[0061] The embodiment of implant 130 is not circular in overall outsideappearance, as is the embodiment 110 of FIGS. 14 and 15. In particular,with respect to the embodiment of implant 130 of FIGS. 16 and 17, thisembodiment is truncated so that the lateral side 140, 142 are flattenedwith the upper and lower sides 144, 146 being elongated in order tocapture and create a saddle for the upper and lower spinous processes.The upper and lower sides, 144, 146 are rounded to provide a moreanatomical implant which is compatible with the spinous processes.

[0062] If it is desired, and in order to assure that the first member132 and the second member 134 are aligned, key 148 and keyway 150 aredesigned to mate in a particular manner. Key 148 includes at least oneflattened surface, such as flattened surface 152, which mates to anappropriately flattened surface 154 of the keyway 150. In this manner,the first member is appropriately mated to the second member in order toform appropriate upper and lower saddles holding the implant 130relative to the upper and lower spinous processes.

[0063]FIG. 16a depicts second member 134 in combination with a roundednose lead-in plug 135. Lead-in plug 135 includes a bore 137 which canfit snugly over key 148. In this configuration, the lead-in plug 135 canbe used to assist in the placement of the second member 134 betweenspinous processes. Once the second member 134 is appropriatelypositioned, the lead-in plug 135 can be removed. It is to be understoodthat the lead-in plug 135 can have other shapes such as pyramids andcones to assist in urging apart the spinous processes and soft tissuesin order to position the second member 134.

[0064] Embodiment of FIGS. 18, 19 and 20

[0065] The implant 330 as shown in FIG. 18 is comprised of first andsecond mating wedges 332 and 334. In order to implant these wedges 332,334, the spinous processes are accessed from both sides and then a toolis used to push the wedges towards each other. As the wedges are urgedtowards each other, the wedges move relative to each other so that thecombined dimension of the implant 330 located between the upper andlower spinous processes 336, 338 (FIG. 20), increases, therebydistracting the spinous processes. It is noted that the wedges 332, 334include saddle 340, 342, which receiving the spinous processes 336, 338.These saddles have the advantages as described hereinabove.

[0066] The first or second wedges 332, 334 have a mating arrangementwhich includes a channel 344 and a projection of 346 which can be urgedinto the channel in order to lock the wedges 332, 334 together. Thechannel 334 is undercut in order to keep the projection from separatingtherefrom . Further, as in other devices described herein, a detent canbe located in one of the channel and the projection, with acomplimentary recess in the other of the channel and the projection.Once these two snap together, the wedges are prevented from slidingrelative to the other in the channel 344.

[0067] While the above embodiment was described with respect to wedges,the wedges could also have been designed substantially as cones with allthe same features and advantages.

Embodiments of FIGS. 21 and 22

[0068] The implant 370 is comprised of first and second distraction cone372, 374. These cones are made of a flexible material. The cones arepositioned on either side of the spinous processes 376, 378 as shown inFIG. 21. Using appropriate tool as shown hereinabove, the distractioncones 372, 374 are urged together. As they are urged together, the conesdistract the spinous processes as shown in FIG. 22. Once this hasoccurred, an appropriate screw or other type of fastening mechanism 380can be used to maintain the position of the distraction cones 372, 374.The advantage of this arrangement is that the implant 370 isself-distracting and also that the implant, being flexible, molds aboutthe spinous processes as shown in FIG. 22.

[0069] Embodiments of FIG. 23, 24 and 25

[0070] In FIGS. 23 and 24, another embodiment of the implant 170 isdepicted. This implant is guided in place using an L-shaped guide 172which can have a concave cross-section such as the cross-section 52 ofretraction tool 50 in FIG. 6 in order to cradle and guide the implant170 in position. Preferably a small incision would be made into the backof the patient and the L-shaped guide tool 172 inserted between theadjacent spinous processes. The implant 170 would be mounted on the endof insertion tool 174 and urged into position between the spinousprocesses. The act of urging the implant into position could cause thespinous processes to be further distracted if that is required. Prior tothe insertion of the L-shaped guide tool 172, a distraction tool such asshown in FIG. 13 could be used to initially distract the spinousprocesses.

[0071] Implant 170 can be made of a deformable material so that it canbe urged into place and so that it can somewhat conform to the shape ofthe upper and lower spinous processes. This deformable material would bepreferably an elastic material. The advantage of such a material wouldbe that the load forces between the implant and the spinous processeswould be distributed over a much broader surface area. Further, theimplant would mold itself to an irregular spinous process shape in orderto locate the implant relative to spinous processes.

[0072] With respect to FIG. 25, this implant 176 can be inserted over aguide wire, guide tool or stylet 178. Initially, the guide wire 178 ispositioned through a small incision to the back of the patient to aposition between the adjacent spinous processes. After this hasoccurred, the implant is threaded over the guide wire 178 and urged intoposition between the spinous processes. This urging can further distractthe spinous processes if further distraction is required. Once theimplant is in place, the guide tool 178 is removed and the incisionclosed. The insertion tools of FIGS. 23 and 24 can also be used ifdesired.

Embodiment of FIGS. 26, 27 and 28

[0073] The embodiment shown in FIGS. 26, 27 and 28 uses an implantsimilar to that depicted in FIGS. 8 and 9 with different insertiontools. As can be seen in FIG. 26, an L-shaped distraction tool 190 issimilar to L-shaped distraction tool 80 (FIG. 12), is used to distractthe first and second spinous processes 192, 194. After this hasoccurred, an insertion tool 196 is placed between the spinous processes192, 194. Insertion tool 196 includes a handle 198 to which is mounted asquare-shaped ring 200.

[0074] The distraction tool 190 can be inserted through a small incisionin the back in order to spread apart the spinous processes. Through thesame incision which has been slightly enlarged laterally, an upper end202 of ring 200 can be initially inserted followed by the remainder ofthe ring 200. Once the ring is inserted, the ring can be rotatedslightly by moving handle 198 downwardly in order to further wedge thespinous processes apart. Once this has been accomplished, an implantsuch as implant 204 can be inserted through the ring and properlypositioned using implant handle 206. Thereafter, the implant handle 206and the insertion tool 196 can be removed.

Embodiments of FIGS. 29, 30, 31, 32 and 33

[0075] As can be seen in FIGS. 29 and 30, the implants 210, 212, canhave different shapes when viewed from the side. These implants aresimilar to the above-referenced implants 58 (FIG. 8) and 204 (FIG. 28).These implants have cross-sections similar to that shown in FIG. 10which includes saddles in order to receive and hold the adjacent spinousprocesses.

[0076] As can be seen in FIGS. 31, 32 and 33, these implants can beplaced in different positions with respect to the spinous process 214.Preferably as shown in FIG. 33, the implant 210 is placed closest to thelamina 216. Being so positioned, the implant 210 is close to theinstantaneous axis of rotation 218 of the spinal column, and the implantwould experience least forces caused by movement of the spine. Thus,theoretically, this is the optimal location for the implant.

[0077] As can be seen in FIGS. 31 and 32, the implant can be placedmidway along the spinous process (FIG. 32) and towards the posterioraspect of the spinous process (FIG. 31). As positioned shown in FIG. 31,the greatest force would be placed on the implant 210 due to acombination of compression and extension of the spinal column.

Embodiment of FIGS. 34 and 35

[0078] Another embodiment of the invention is shown in FIGS. 34 and 35.In these figures, implant 220 is comprised of a plurality of individualleaves 222 which are substantially V-shaped. The leaves includeinterlocking indentations or detents 224. That is, each leaf includes anindentation with a corresponding protrusion such that a protrusion ofone leaf mates with an indentation of an adjacent leaf. Also associatedwith this embodiment is an insertion tool 226 which has a blunt end 228which conforms to the shape of an individual leaf 222. For insertion ofthis implant into the space between the spinous processes as shown inFIG. 29, the insertion tool 226 first insert a single leaf 220. Afterthat has occurred, the insertion tool then inserts a second leaf withthe protrusion 224 of the second leaf snapping into correspondingindentation made by the protrusion 224 of the first leaf. This processwould reoccur with third and subsequent leaves until the appropriatespacing between the spinous processes was built up. As can be seen inFIG. 29, the lateral edges 229 of the individual leaves 222 are slightlycurved upwardly in order to form a saddle for receiving the upper andlower spinous processes.

Embodiments of FIGS. 36, 37 and 38

[0079] The embodiments of FIGS. 36, 37 and 38 which include implants230, 232, and 234 respectively, are designed in such a manner so theimplant locks itself into position once it is properly positionedbetween the spinous processes. Implant 220 is essentially a series oftruncated cones and includes a plurality of ever expanding steps 236.

[0080] These steps are formed by the conical bodies starting with thenose body 238 followed there behind by conical body 240. Essentially,the implant 234 looks like a fir tree placed on its side.

[0081] The implant 230 is inserted laterally throughout the openingbetween upper and lower spinous processes. The first body 238 causes theinitial distraction. Each successive conical body distracts the spinousprocesses a further incremental amount. When the desired distraction hasbeen reached, the spinous processes are locked into position by steps236. At this point, if desired, the initial nose body 238 of the implantand other bodies 240 can be broken, snapped or sawed off if desired inorder to minimize the size of the implant 230. In order for a portion ofthe implant 230 to be broken or snapped off, the intersection betweenbodies such as body 238 and 240, which is intersection line 242, wouldbe somewhat weaken with the appropriate removal of material. It is notedthat only the intersection lines of the initial conical bodies need tobe so weakened. Thus, intersection line 244 between the bodies whichremain between the spinous processes would not need to be weaker, asthere would be no intention that the implant would be broken off at thispoint.

[0082]FIG. 37 shows implant 232 positioned between upper and lowerspinous processes. This implant is wedge-shaped or triangular shaped incross-sectioned and includes bore pluralities 245 and 246. Through thesebores can be placed locking pins 248 and 250. The triangular orwedged-shaped implant can be urged laterally between and thus distractthe upper and lower spinous processes. Once the appropriate distractionis reached, pins 248, 250 can be inserted through the appropriate boresof the bore pluralities 245 and 246 in order to lock the spinousprocesses in a V-shaped valley formed by pins 248, 250 on the one handand the ramped surface 233, 235 on the other hand.

[0083] Turning to FIG. 38, the implant 234 has a triangular-shaped orwedge-shaped body similar to that shown in FIG. 32. In this embodiment,tab 252, 254 are pivotally mounted to the triangular shaped body 234.Once the implant 234 is appropriately positioned in order to distractthe spinous processes to the desired amount, the tabs 252, 254 rotateinto position in order to hold the implant 234 in the appropriatePosition.

Embodiment of FIGS. 39 and 40

[0084] In the embodiment of FIGS. 39 and 40, cannula 258 is insertedthrough a small incision to a position between upper and lower spinousprocesses. Once the cannula is properly inserted, an implant 260 ispushed through the cannula 258 using an insertion tool 262. The implant260 includes a plurality of ribs or indentation 264 that assist inpositioning the implant 260 relative to the upper and lower spinalprocesses. Once the implant 260 is in position, the cannula 258 iswithdrawn so that the implant 260 comes in contact with and wedgesbetween the spinous processes. The cannula 258 is somewhat conical inshape with the nose end 266 being somewhat smaller than the distal end268 in order to effect the insertion of the cannula into the spacebetween the spinous processes.

[0085] Further, a plurality of cannula can be used instead of one, witheach cannula being slightly bigger than one before. In the method of theinvention, the first smaller cannula would be inserted followed bysuccessively larger cannula being placed over the previous smallercannula. The smaller cannula would then be withdrawn from the center ofthe larger cannula. Once the largest cannula is in place, and theopening of the skin accordingly expanded, the implant, which isaccommodated by only the larger cannula, is inserted through the largercannula and into position.

Embodiments of FIGS. 41, 42 and 43

[0086] The precurved implant 270 in FIGS. 41 and 42, and precurvedimplant 272 in FIG. 43 have common introduction techniques whichincludes a guide wire, guide tool, or stylet 274. For both embodiments,the guide wire 274 is appropriately positioned through the skin of thepatient and into the space between the spinous processes. After this isaccomplished, the implant is directed over the guide wire and intoposition between the spinous processes. The precurved nature of theimplant assist in (1) positioning the implant through a first smallincision in the patient's skin on one side of the space between twospinous processes and (2) guiding the implant toward a second smallincision in the patient's skin on the other side of the space betweenthe two spinous processes. With respect to the implant 270, the implantincludes a conical introduction nose 276 and a distal portion 278. Asthe nose 276 is inserted between the spinous processes, this causesdistraction of the spinous processes. Break lines 280, 282 areestablished at opposite sides of the implant 270. Once the implant isproperly positioned over the guide wire between the spinous processes,the nose portion 276 and the distal portion 278 can be broken off alongthe break lines, through the above two incisions, in order to leave theimplant 270 in position.

[0087] Although only two break lines 280, 282 are depicted, multiplebreak lines can be provided on implant 270 so that the implant cancontinue to be fed over the guide wire 278 until the appropriate widthof the implant 270 creates the desired amount of distraction. Asdescribed hereinabove, the break lines can be created by perforating orotherwise weakening the implant 270 so that the appropriate portions canbe snapped or sawed off.

[0088] With respect to the precurved implant 272, this implant issimilar in design to the implant 230 shown in FIG. 36. This implant 272in FIG. 47, however, is precurved and inserted over a guide wire 274 toa position between the spinous processes. As with implant 230 in FIG.43, once the appropriate level of this distraction has been reached andif desired, sections of the implant 272 can be broken, snapped or sawedoff as described hereinabove in order to leave a portion of the implantwedged between the upper and lower spinous processes.

Embodiment of FIG. 44

[0089] A further embodiment of the invention is shown in FIG. 44. Thisembodiment includes a combination insertion tool and implant 290. Theinsertion tool and implant 290 is in the shape of a ring which is hingedat point 292. The ring is formed by a first elongated and conicallyshaped member 294 and a second elongated and conically shaped member296. Members 294 and 296 terminate in points and through the use ofhinge 292 are aligned and meet. Through similar incisions on both sidesof the spinous processes, first member and second member are insertedthrough the skins of the patient and are mated together between thespinous processes. After this has occurred, the implant 290 is rotated,for example clockwise, so that increasingly widening portions of thefirst member 292 are used to distract the first and second spinousprocesses. When the appropriate level of distraction has occurred, theremainder of the ring before and after the section which is locatedbetween the spinous processes can be broken off as taught hereinabove inorder to maintain the desired distraction. Alternatively, with a smallenough ring, the entire ring can be left in place with the spinousprocesses distracted.

Embodiment of FIG. 45

[0090] In FIG. 45, the implant 300 is comprised of a plurality of rodsor stylets 302 which are inserted between the upper and lower spinousprocesses. The rods are designed much as described hereinabove so thatthey may be broken, snapped or cut off. Once these are inserted and theappropriate distraction has been reached, the stylets are broken off anda segment of each stylet remains in order to maintain distraction of thespinous process.

Embodiment of FIGS. 46 and 47

[0091] Implant 310 of FIGS. 46 and 47 is comprised of a shape memorymaterial which coils upon being released. The material is straightenedout in a delivery tool 312. The delivery tool is in position betweenupper and lower spinous processes 314, 316. The material is then pushedthrough the delivery tool. As it is released from the delivery end 318of the delivery tool, the material coils, distracting the spinousprocesses to the desired amount. Once this distraction has beenachieved, the material is cut and the delivery tool removed.

Embodiments of FIGS. 48, 49, 50 and 51

[0092] As can be seen in FIG. 48, the implant 320 is delivered betweenupper and lower spinous processes 322 and 324, by delivery tool 326.Once the implant 320 is in place between the spinous processes, thedelivery tool is given a 900 twist so that the implant goes from theorientation as shown in FIG. 49, with longest dimension substantiallyperpendicular to the spinous processes, to the orientation shown in FIG.50 where the longest dimension is in line with and parallel to thespinous processes. This rotation causes the desired distraction betweenthe spinous processes. Implant 320 includes opposed recesses 321 and 323located at the ends thereof. Rotation of the implant 320 causes thespinous processes to become lodged in these recesses.

[0093] Alternatively, the insertion tool 326 can be used to insertmultiple implants 320, 321 into the space between the spinous processes322, 324 (FIG. 51). Multiple implants 320, 321 can be inserted until theappropriate amount of distraction is built up. It is to be understood inthis situation that one implant would lock to another implant by use of,for example, a channel arrangement wherein a projection from one of theimplants would be received into and locked into a channel of the otherimplant. Such a channel arrangement is depicted with respect to theother embodiment.

Embodiment of FIGS. 52, 53, 54, 55 a and 55 b

[0094] The embodiment of FIGS. 52 through 55b is comprised of afluid-filled dynamic distraction implant 350. This implant includes amembrane 352 which is placed over pre-bent insertion rod 354 and theninserted through an incision on one side of the spinous process 356. Thebent insertion rod, with the implant 350 thereover, is guided betweenappropriate spinous processes. After this occurs, the insertion rod 354is removed leaving the flexible implant in place. The implant 350 isthen connected to a source of fluid (gas, liquid, gel and the like) andthe fluid is forced into the implant causing it to expand as shown inFIG. 54, distracting the spinal processes to the desired amount. Oncethe desired amount of distraction has occurred, the implant 350 isclosed off as is shown in FIG. 55a. The implant 350 being flexible, canmold to the spinous processes which may be of irregular shape, thusassuring positioning. Further, implant 350 acts as a shock absorber,damping forces and stresses between the implant and the spinousprocesses.

[0095] A variety of materials can be used to make the implant and thefluid which is forced into the implant. By way of example only,viscoelastic substances such as methylcellulose, or hyaluronic acid canbe used to fill the implant. Further, materials which are initially afluid, but later solidify, can be inserted in order to cause thenecessary distraction. As the materials solidify, they mold into acustom shape about the spinous processes and accordingly are held inposition at least with respect to one of two adjacent spinous processes.Thus, it can be appreciated that using this embodiment and appropriateinsertion tools the implant can be formed about one spinous process insuch a manner that the implant stays positioned with respect to thatspinous process (FIG. 55b). With such an embodiment, a single implantcan be used as an extension stop for spinous process located on eitherside, without restricting flexion of the spinal column.

[0096] It is to be understood that many of the other implants disclosedherein can be modified so that they receive a fluid in order toestablish and maintain a desired distraction much in the manner asimplant 350 receives a fluid.

[0097] Embodiment of FIGS. 56, 57 and 58

[0098] The implant 360 as shown in FIG. 56 is comprised of a shapememory material such as a plastic or a metal. A curved introductory tool362 is positioned between the appropriate spinous processes as describedhereinabove. Once this has occurred, bore 364 of the implant is receivedover the tool. This act can cause the implant to straighten out. Theimplant is then urged into position and thereby distracts the spinousprocesses. When this has occurred, the insertion tool 362 is removed,allowing the implant to assume its pre-straightened configuration and isthereby secured about one of the spinous processes. Such an arrangementallows for an implant that is an extension stop and does not inhibitflexion of the spinous column. Alternatively, the implant can betemperature sensitive. That is to say that the implant would be morestraightened initially, but become more curved when it was warmed by thetemperature of the patient's body.

Embodiments of FIGS. 59 and 60

[0099] In this embodiment, the implant 380 is comprised of a pluralityof interlocking leaves 382. Initially, a first leaf is positionedbetween opposed spinous processes 384, 386. Then subsequently, leafs 382are interposed between the spinous processes until the desireddistraction has been built up. The leaves are somewhat spring-like inorder to absorb the shock and can somewhat conform to the spinousprocesses.

Embodiment of FIG. 61

[0100] The implant 390 of FIG. 61 includes the placement of shields 392,394 over adjacent spinous processes 396, 398. The shields are used toprevent damage to the spinous processes. These shields include apertureswhich receives a self-tapping screw 400, 402. In practice, the shieldsare affixed to the spinous processes and the spinous processes aredistracted in the appropriate amount. Once this has occurred, a rod 404is used to hold the distracted position by being screwed into each ofthe spinous processes through the aperture in the shields using thescrews as depicted in FIG. 61.

[0101] Embodiment of FIGS. 62 and 63

[0102] Implant 410 of FIGS. 62, 63 is comprised of first and secondmembers 412, 414 which can be mated together using an appropriate screwand threaded bore arrangement to form the implant 410. Main member 412and mating member 414 form implant 410. Accordingly, the implant 410would have a plurality of members 414 for use with a standardized firstmember 412. FIGS. 62 and 64 show different types of mating members 414.In FIG. 62, the mating member 414 includes projections 416 and 418 whichact like shims. These projections are used to project into the space ofsaddles 420, 422 of the first member 412. These projections 416, 418 canbe of varying lengths in order to accommodate different sizes of spinousprocesses. A groove 424 is placed between the projections 416, 418 andmates with an extension 426 of the first member 412.

[0103] As shown in FIG. 63, the projections of the embodiment shown inFIG. 62 are removed and recesses 428, 430 are substituted therefor.These recesses expand the area of the saddles 420, 422 in order toaccommodate larger spinous processes.

Embodiment of FIGS. 64, 65 and 66

[0104] The embodiments of FIGS. 64, 65 and 66 are similar in design andconcept to the embodiment of FIGS. 62 and 63. In FIG. 64, the implant500 includes the first and second members 502, 504. These members can besecured together with appropriate screws or other fastening means astaught in other embodiments. Implant 500 includes first and secondsaddles 506, 508 which are formed between the ends of first and secondmembers 502, 504. These saddles 506, 508 are used to receive and cradlethe adjacent spinous processes. As can be seen in FIG. 64, each saddle506, 508 is defined by a single projection or leg 510, 512, whichextends from the appropriate first and second members 502, 504. Unlikethe embodiment found in FIGS. 62 and 63, each of the saddles is definedby only a single leg as the ligaments and other tissues associated withthe spinous processes can be used to ensure that the implant is held inan appropriate position. With the configuration of FIG. 64, it is easierto position the implant relative to the spinous processes as each saddleis defined by only a single leg and thus the first and second memberscan be more easily worked into position between the various tissues.

[0105] In the embodiment of FIG. 65, the implant 520 is comprised of asingle piece having saddles 522 and 524. The saddles are defined by asingle leg 526, 528 respectively. In order for this implant 520 to bepositioned between the spinous processes, an incision is made betweenlateral sides of adjacent spinous processes. The single leg 526 isdirected through the incision to a position adjacent to an oppositelateral side of the spinous process with the spinous process cradled inthe saddle 522. The spinous processes are then urged apart until saddle524 can be pivoted into position into engagement with the other spinousprocess in order to maintain the distraction between the two adjacentspinous processes.

[0106] The embodiment of FIG. 66 is similar to that of FIG. 65 with animplant 530 and first and second saddles 532 and 534. Associated witheach saddle is a tether 536, 538 respectively. The tethers are made offlexible materials known in the trade and industry and are positionedthrough bores in the implant 530. Once appropriately positioned, thetethers can be tied off. It is to be understood that the tethers are notmeant to be used to immobilize one spinous process relative to theother, but are used to guide motion of the spinous processes relative toeach other so that the implant 530 can be used as an extension stop anda flexion non-inhibitor. In other words, the saddles 532, 534 are usedto stop spinal column backward bending and extension. However, thetethers do not inhibit forward bending and spinal column flexion.

Embodiments of FIGS. 67, 68

[0107] The implant 550 is Z-shaped and includes a central body 552 andfirst and second arms 554, 556, extending in opposite directionstherefrom. The central body 552 of the implant 550 includes first andsecond saddles 558 and 560. The first and second saddles 558 and 560would receive upper and lower spinous processes 562, 568. The arms 554,556 are accordingly located adjacent the distal end 566 (FIG. 68) of thecentral body 552. The first and second arms 554, 556, act to inhibitforward movement, migration or slippage of the implant 550 toward thespinal canal and keep the implant in place relative to the first andsecond spinal processes. This prevents the implant from pressing down onthe ligamentum flavum and the dura. In a preferred embodiment, thecentral body would have a height of about 10 mm with each of the arms554, 556 have a height of also about 10 mm. Depending on the patient,the height of the body could vary from about less than 10 mm to aboutgreater than 24 mm. As can be seen in FIGS. 67 and 68, the first andsecond arms 554, 556 are additionally contoured in order to accept theupper and lower spinous processes 556, 558. In particular, the arms 554,556 as can be seen with respect to arm 554 have a slightly outwardlybowed portion 568 (FIG. 68) with a distal end 570 which is slightlyinwardly bowed. This configuration allows the arm to fit about thespinous process with the distal end 570 somewhat urged against thespinous process in order to guide the motion of the spinous processrelative to the implant. These arms 554, 556 could if desired to be mademore flexible than the central body 552 by making arms 554, 556 thinand/or with perforations, and/or other material different than that ofthe central body 550. As with the last embodiment, this embodiment canbe urged into position between adjacent spinous processes by directingan arm into a lateral incision so that the central body 552 can befinally positioned between spinous processes.

Embodiment of FIGS. 69, 70, 71 and 71 a

[0108]FIGS. 69, 70 and 71 are perspective front, end, and side views ofimplant 580 of the invention. This implant includes a central body 582which has first and second saddles 584, 586 for receiving adjacentspinous processes. Additionally, the implant 580 includes first andsecond arms 588 and 590. The arms, as with the past embodiment, preventforward migration or slippage of the implant toward the spinal canal.First arm 588 projects outwardly from the first saddle 584 and secondarm 590 projects outwardly from the second saddle 586. In a preferredembodiment, the first arm 588 is located adjacent to the distal end 600of the central body 582 and proceeds only partly along the length of thecentral body 582. The first arm 588 is substantially perpendicular tothe central body as shown in FIG. 70. Further, the first arm 588, aswell as the second arm 590, is anatomically rounded.

[0109] The second arm 590, projecting from second saddle 586, is locatedsomewhat rearward of the distal end 600, and extends partially along thelength of the central body 582. The second arm 590 projects at acompound angle from the central body 582. As can be seen in FIGS. 70 and71, the second arm 590 is shown to be at about an angle of 45° from thesaddle 586 (FIG. 70). Additionally, the second arm 590 is at an angle ofabout 45° relative to the length of the central body 580 as shown inFIG. 71. It is to be understood that other compound angles are withinthe spirit and scope of the invention as claimed.

[0110] In a preferred embodiment, the first and second arms 588, 590have a length which is about the same as the width of the central body582. Preferably, the length of each arm is about 10 mm and the width ofthe central body is about 10 mm. However, the bodies with the widths of24 mm and greater are within the spirit and scope of the invention,along with first and second arms ranging from about 10 mm to greaterthan about 24 mm. Further, it is contemplated that the embodiment couldinclude a central body having a width of about or greater than 24 mmwith arms being at about 10 mm.

[0111] It is to be understood that the embodiment of FIGS. 69, 70 and 71as well as the embodiment of FIGS. 67 and 68 are designed to preferablybe positioned between the L4-L5 and the L5-S1 vertebral pairs. Theembodiment of FIGS. 69, 70, 71 is particularly designed for the L5-S1position with the arms being designed to conform to the sloping surfacesfound therebetween. The first and second arms are thus contoured so thatthey lie flat against the lamina of the vertebra which has a slightangle.

[0112] The embodiment of FIG. 69, 70, and 71 as with the embodiment ofFIGS. 67 and 68 is Z-shaped in configuration so that it may be insertedfrom one lateral side to a position between adjacent spinous processes.A first arm, followed by the central body, is guided through the spacebetween the spinous processes. Such an arrangement only requires that aincision on one side of the spinous process be made in order tosuccessfully implant the device between the two spinous processes.

[0113] The implant 610 of FIG. 71a is similar to that immediately abovewith the first arm 612 located on the same side of the implant as thesecond arm 614. The first and second saddle 616, 618 are slightlymodified in that distal portion 620, 622 are somewhat flattened from thenormal saddle shape in order to allow the implant to be positionedbetween the spinous processes from one side. Once in position, theligaments and tissues associated with the spinous processes would holdthe implant into position. Tethers also could be used if desired.

Embodiment of FIGS. 72, 73

[0114] Implant 630 is also designed so that it can be inserted from oneside of adjacent spinous processes. This insert 630 includes a centralbody 632 with the first and second arms 634, 636 extending on eitherside thereof. As can be seen in FIG. 72, a plunger 638 is positioned toextend from an end of the central body 632. As shown in FIG. 72, theplunger 638 is fully extended and as shown in FIG. 73, the plunger 638is received within the central body 632 of the implant 630. With theplunger received into the implant 632, the third and fourth arms orhooks 640, 642 can extend outwardly from the central body 632. The thirdand fourth arms or hooks 640, 642 can be comprised of a variety ofmaterials, such as for example, shape memory metal materials ormaterials which have a springy quality.

[0115] For purposes of positioning the implant 630 between adjacentspinous processes, the plunger 638 is pulled outwardly as shown in FIG.72. The central body 632 is then positioned between adjacent spinousprocesses and the plunger 638 is allowed to move to the position of FIG.73 so that the third and fourth arms 640, 642 can project outwardly fromthe central body 632 in order to hold the implant 630 in positionbetween the spinous processes.

[0116] Plunger 638 can be spring biased to the position as shown in FIG.73 or can include detents or other mechanisms which lock it into thatposition. Further, the third and fourth arms themselves, as deployed,can keep the plunger in the position as shown in FIG. 73.

Embodiments of FIGS. 74, 75, 76, 77, and 78

[0117] Other embodiments of the invention are shown in FIGS. 74 through78. FIGS. 74, 75 and 76 disclose implant 700. Implant 700 isparticularly suited for implantation between the L4-L5 and L5-S1vertebra. As can be seen in FIG. 74, the implant 700 includes a centralbody 702 which has a bore 704 provided therein. Bore 704 is used inorder to adjust the modulus of elasticity of the implant so that it ispreferably approximately two times the anatomical load placed on thevertebra in extension. In other words, the implant 700 is approximatelytwo times stiffer than the normal load placed on the implant. Such anarrangement is made in order to ensure that the implant is somewhatflexible in order to reduce potential resorption of the bone adjacent tothe implant. Other modulus values can be used and be within the spiritof the invention.

[0118] Implant 700 includes first and second saddle 706, 708 which areused to receive and spread the load from the upper and lower spinousprocesses. The saddle 706 is defined by first and second arms 710 and712. The second saddle 708 is defined by third and fourth arms 714 and716. As can be seen in FIG. 74, the first arm 710, in a preferredembodiment, is approximately two times the length of the body 702 withthe second arm being approximately less than a quarter length of thebody. Third arm 714 is approximately one times the length of the body702 with the fourth arm 716 being, in this preferred embodiment,approximately one and a half times the length of the body 702. The armsare designed in such a way that the implant (1) can be easily andconveniently inserted between the adjacent spinous processes, (2) willnot migrate forwardly toward the spinal canal, and (3) will hold itsposition through flexion and extension as well as lateral bending of thespinal column.

[0119] First arm 710 is in addition designed to accommodate the shape ofthe vertebra. As can be seen in FIG. 74, the first arm 710 becomesnarrower as it extends away from the body 702. The first arm 710includes a sloping portion 718 followed by a small recess 720 ending ina rounded portion 722 adjacent to the end 724. This design is providedto accommodate the anatomical form of for example the L4 vertebra. It isto be understood that these vertebra have a number of surfaces atroughly 300 angles and that the sloping surfaces of this embodiment andthe embodiments shown in FIGS. 77 and 78 are designed to accommodatethese surfaces. These embodiments can be further modified in order toaccommodate other angles and shapes.

[0120] The second arm 712 is small so that it is easy to insert betweenthe spinous processes, yet still define the saddle 706. The fourth arm716 is larger than the third arm 714, both of which are smaller than thefirst arm 710. The third and fourth arms are designed so that theydefine the saddle 706, guide the spinous processes relative to theimplant 700 during movement of the spinal column, and yet are of a sizewhich makes the implant easy to position between the spinous processes.

[0121] The procedure, by way of example only, for implanting the implant700 can be to make an incision laterally between two spinous processesand then initially insert first arm 710 between the spinous processes.The implant and/or appropriate tools would be used to distract thespinous processes allowing the third leg 714 and the central body 702 tofit through the space between the spinous processes. The third leg 714would then come to rest adjacent the lower spinous processes on theopposite side with the spinous processes resting in the first and secondsaddle 706, 708. The longer fourth leg 716 would then assist in thepositioning of the implant 700.

[0122]FIG. 77 includes an implant 740 which is similar to implant 700and thus have similar numbering. The saddle 706, 708 of implant 740 havebeen cantered or sloped in order to accommodate the bone structurebetween, by way of example, the L4-L5 and the L5-S1 vertebra. Asindicated above, the vertebra in this area have a number of slopingsurfaces in the range of about 300. Accordingly, saddle 706 is sloped atless than 30° and preferably about 20° while saddle 708 is sloped atabout 30° and preferably more than 30°.

[0123] The implant 760 as shown in FIG. 78 is similar to implant 700 inFIG. 74 and is similarly numbered. Implant 760 includes third and fourthlegs 714, 716 which have sloping portions 762, 764 which slope towardends 766, 768 of third and fourth arm 714, 716 respectively. The slopingportions accommodate the form of the lower vertebra against which theyare positioned. In the preferred embodiment, the sloping portions are ofabout 300. However, it is to be understood that sloping portions whichare substantially greater and substantially less than 30° can beincluded and be within the spirit and scope of the invention. IndustrialApplicability

[0124] From the above, it is evident that the present invention can beused to relieve pain caused by spinal stenosis in the form of, by way ofexample only, central canal stenosis or foraminal (lateral) stenosis.These implants have the ability to flatten the natural curvature of thespine and open the neural foramen and the spacing between adjacentvertebra to relieve problems associated with the above-mentioned lateraland central stenosis. Additionally, the invention can be used to relievepain associated with facet arthropathy. The present invention isminimally invasive and can be used on an outpatient basis.

[0125] Additional aspects, objects and advantages of the invention canbe obtained through a review of the appendant claims and figures.

[0126] It is to be understood that other embodiments can be fabricatedand come within the spirit and scope of the claims.

We claim:
 1. An implant for relieving pain associated with the spinalcolumn comprising: a device that is adapted to be positionable between afirst spinous process and a second spinous process; said deviceincluding a first means for not limiting flexion of the spinal column;and said device including a second means for limiting extension of thespinal column.
 2. The implant of claim 1 wherein: said first means doesnot prevent the spreading apart of the first spinous process from thesecond spinous process; and said second means does stop the motion ofthe first spinous process and the second spinous process to toward eachother.
 3. The implant of claim 1 wherein: said device includes a spinousprocess containment member; and said first means includes an open end ofsaid spinous process containment member; and said second means includesa saddle of said spinous process containment member.
 4. The implant ofclaim 1 wherein: said device includes a means for distracting the firstspinous process from the second spinous process.
 5. The implant of claim4 wherein: said distraction means can create a distraction of at leastabout 5 mm upon insertion between the first and the second spinousprocess.
 6. The implant of claim 4 wherein: said distraction means cancreate a distraction of about 5 mm to about 15 mm upon insertion.
 7. Aspinal column implant comprising: a device positionable between a firstspinous process and a second spinous process; said device including aspinal column extension stop; and wherein said device does not inhibitspinal column flexion.
 8. A spinal column implant comprising: a devicethat is adapted to be positionable between a first spinous process and asecond spinous process; said device includes a spinal column extensionstop; and said device includes a spinal column flexion non-inhibitor. 9.The implant of claim 8 wherein: said device is comprised of one ofstainless steel, titanium, ceramic, a composite material, an elasticmaterial, a polymer, and a plastic material.
 10. An implant forrelieving pain associated with the spinal column comprising: a devicethat is adapted to be positionable between a first spinous process and asecond spinous process; and said device including means for distractingthe first and the second spinous processes upon implant in order torelieve pain through distraction.
 11. The implant of claim 10 wherein:said distracting means causes distraction of at least about 5 mm betweenthe first and the second spinous process.
 12. The implant of claim 10wherein: said distracting means causes distraction of about 5 mm toabout 15 mm.
 13. An implant for relieving pain associated with thespinal column comprising: a device that is adapted to be positionablebetween a first spinous process and a second spinous process; and saiddevice including a distracting wedge that can distract the first and thesecond spinous processes.
 14. The implant of claim 13 wherein: saiddistraction wedge can distract the first and the second spinousprocesses by about 5 mm.
 15. The implant of claim 8 wherein: said spinalcolumn extension stop is adjustable to fit the size of various spinousprocesses.
 16. The implant of claim 8 wherein: said spinal columnextension stop is adapted to be associated with the first spinousprocess another spinal column extension stop adapted to be associatedwith the second spinous process, said spinal column extension stopspaced from the another spinal column extension stop; and a lengthadjustor located between the spinal column extension stops in order toselectively adjust the distance between the extension stops.
 17. Theimplant of claim 8 wherein: said device is positionable adjacent to theposterior aspects of the first and the second spinous processes.
 18. Theimplant of claim 8 wherein: said device is positionable adjacent to theaxis of rotation of the spinal column.
 19. The implant of claim 8wherein: said device is positionable adjacent to the lamina of thespinal column.
 20. The implant of claim 8 wherein: said device isflexible in order to avoid bone resorption.
 21. The implant of claim 8wherein: said device is flexible.
 22. The implant of claim 8 wherein:said device includes a first member and a second member and a fastenerthat can secure the first member to the second member; and with saidfirst member fastened to said second member with said fastener, saidfastened together first and second members define said extension stopand another extension stop.
 23. The implant of claim 22 wherein: saidextension stop is spaced from said another extension stop; and with thedevice implanted in a spinal column the extension stop is associatedwith the first spinous process and the another extension stop isassociated with the second spinous process.
 24. The implant of claim 22wherein: said second member is selected from a plurality of differentlysized second members that can accommodate variously sized spinousprocesses.
 25. The implant of clam 22 wherein: said fastener is part ofeither the first member or the second member.
 26. An implant forrelieving pain associated with the spinal column comprising: a devicethat is adapted to be positionable between a first spinous process and asecond spinous process; and the device is adapted to increase the volumeof a spinal canal and/or a neural foramen in said spinal column inassociation with the positioning of the device between the spinousprocesses.
 27. The implant of claim 26 wherein: the device inhibits anydecrease in the volume of the spinal cord and/or neural foramen as thespinal column is placed in extension.
 28. The implant of claim 8wherein: said device includes a shock absorber.
 29. The implant of claim13 wherein: said device includes a shock absorber.
 30. The implant ofclaim 26 wherein: said device includes a shock absorber.
 31. The implantof claim 8 wherein: said device has anatomically rounded features. 32.The implant of claim 13 wherein: said device has anatomically roundedfeatures.
 33. The implant of claim 26 wherein: said device hasanatomically rounded features.
 34. The implant of claim 8 wherein: saiddevice is perforated in order to increase flexibility.
 35. The implantof claim 13 wherein: said device is perforated in order to increaseflexibility.
 36. The implant of claim 26 wherein: said device isperforated in order to increase flexibility.
 37. A method of relievingpain due to the development of spinal stenosis and the like in thespinal column including the steps of: accessing adjacent first andsecond spinous processes of the spinal column; distracting the first andsecond spinous processes a sufficient amount in order to increase thevolume of the spinal canal and/or the neural foramen in the spinalcolumn in order to relieve pain due to the development of spinalstenosis and the like; and implanting a device in order to maintain theamount of distraction required to relieve the pain due to spinalstenosis and the like.
 38. The method of claim 37 including the step of:distracting apart the first and the second spinous process at leastabout 5 mm.
 39. The method of claim 37 including the step of:distracting apart the first and the second spinous process from about 5mm to about 15 mm.
 40. The method of claim 37 wherein: said distractingstep and said implanting step occur simultaneously as the step ofimplanting a device causes distraction.
 41. The method of claim 37wherein: said device includes a distraction wedge; and said distractingstep and said implanting step occur simultaneously as the step ofimplanting a device causes distraction due to the distraction wedgedistracting apart the first and the second spinous process.
 42. A methodof relieving pain due to the development of spinal stenosis and the likein the spinal column including the steps of: accessing adjacent firstand second spinous processes of the spinal column; implanting a devicein order to distract apart the first and second spinous processes asufficient amount in order to increase the volume of the spinal canaland/or neural foramen in the spinal column to relieve pain due to thedevelopment of spinal stenosis and the like; and using the device inorder to maintain the amount of distraction required to relieve the paindue to spinal stenosis and the like.
 43. The method of claim 37including the step of: maintaining intact the superspinous ligament. 44.The method of claim 42 including the step of: maintaining intact thesuperspinous ligament.
 45. The device of claim 8 wherein: said implantprovides for dynamic distraction between the first and the secondspinous processes by including a fluid filled vessel.
 46. The device ofclaim 22 wherein: said fastener is part of the first member and part ofthe second member.
 47. The device of claim 46 wherein: said fastener i sself-engaging such that by urging the first member and the second membertogether in order to assembly the device a portion of the fastener inthe first member engages a second portion of the fastener in the secondmember.
 48. A method of relieving pain due to the development of spinalstenosis and the like in the spinal column including the steps of:accessing adjacent first and second spinous processes of the spinalcolumn with first and second incisions; distracting the first and secondspinous processes a sufficient amount in order to increase the volume ofthe spinal canal and/or neural foramen in the spinal column in order torelieve pain due to the development of spinal stenosis and the like; andimplanting a first portion of a device through said first incision and asecond portion of said device through said second incision, until saiddevices can be mated; said device including a fastener, with thefastener used in a step of securing the first portion to the secondportion in the mated configuration in order to maintain the amount ofdistraction required to relieve the pain due to spinal stenosis and thelike.
 49. The method of claim 48 including: using a tool having a firstarm on to which is mounted the first portion of the device and a secondarm on to which is mounted the second portion of the device in order tourge the first portion and the second portion through the respectivefirst and second incisions and in to mating position.
 50. A method ofrelieving pain due to the development of spinal stenosis and the like inthe spinal column including the steps of: accessing adjacent first andsecond spinous processes of the spinal column with first and secondincisions; implanting a first portion of a device through said firstincision and a second portion of said device through said secondincision, until said devices can be mated, and simultaneouslydistracting the first and second spinous processes a sufficient amountin order to increase the volume of the spinal canal and/or neuralforamen in the spinal column in order to relieve pain; and said deviceincluding a fastener, with the fastener used in a step of securing thefirst portion to the second portion in the mated configuration in orderto maintain the amount of distraction required to relieve the pain. 51.An implant for relieving pain associated with the spinal columncomprising: a device that is adapted to be positionable between a firstspinous process and a second spinous process; said device including afirst forked end and a second forked end; said device including aninterbody which is operably connected to the first and second forkedends so that rotation of the interbody causes the first and secondforked ends to move apart from each other in order to distract the firstand the second spinous processes with respect to each other.
 52. Amethod using an implant for relieving pain associated with the spinalcolumn comprising the steps of: accessing the space between a firstspinous process and a second spinous process of the spinal column;positioning an implant between the first spinous process and the secondspinous process; wherein said implant includes a first means for notlimiting flexion of the spinal column; and said implant including asecond means for limiting extension of the spinal column.
 53. A methodof relieving pain using a spinal column implant comprising the steps ofaccessing the space between a first spinous process and a secondprocess; positioning the implant between the first spinous process andthe second spinous process; wherein said device including a spinalcolumn extension stop; and said device includes a spinal column flexionnon-inhibitor.
 54. The method of claim 48 wherein: the distracting stepincludes wedging the first and second spinous processes apart.
 55. Amethod for relieving pain associated with the spinal column includingthe steps of: accessing first and second spinous processes; distractingthe first and second spinous processes in order to increase the volumeof a spinal cord and/or neural foramen in the spinal column; implantinga device between the first and second spinous processes to do one of (1)further distracting and maintaining the distraction of the first andsecond spinous processes, and (2) maintaining the distraction of thefirst and second spinous processes.
 56. The method of claim 55 whereinthe distracting step includes: multiple distracting steps with a timeperiod between distracting steps in order to allow the tissuesassociated with the spine to creep.
 57. A method for relieving painassociated with the spinal column including the steps of: accessingfirst and second spinous processes; implanting a device in order todistract the first and second spinous processes to increase the volumeof a spinal canal and/or neural foramen in the spinal column; andmaintaining the distraction with the device.
 58. The method of claim 57wherein the implanting step includes: multiple distracting steps with atime period between distracting steps in order to allow the tissuesassociated with the spine to creep.
 59. A method for relieving painassociated with the spinal column comprising the steps of: implanting adevice between a first spinous process and a second spinous process,said device including a first forked end and a second forked end, andsaid device including an interbody piece which is operably connected tothe first and second forked ends so that rotation of the interbody piececauses the first and second forked ends to move apart in order todistract the first and the second spinous processes with respect to eachother; and distracting the spinous processes by rotating the interbodypiece.
 60. The method of claim 42 for relieving pain caused by at leastone of spinal stenosis and facet arthropathy.
 61. An implant forflattening the spine in order to increase the volume of at least one ofthe spinal canal and the neural foramen comprising: a central body withfirst and second saddles which are adapted to receive adjacent spinousprocesses; a first arm projecting from the first saddle, and a secondarm projection from the second saddle; and wherein said central body andthe first and second arms form a Z-shaped structure.
 62. The implant ofclaim 61 wherein: the first and second arms are forward migrationinhibitors which prevent the implant from migrating toward the spinalcanal.
 63. The implant of claim 61 wherein: the first and second armsare contoured to the lamina of the spine.
 64. The implant of claim 61wherein: said implant is designed to conform to the bone structurebetween at least on of the L4-L5 and or the L5-S1 spinous processes. 65.An implant for relieving pain associated with the spinal columncomprising: a device which is adapted to be positioned between a firstspinous process and a second spinous process; said device being Z-shapedwith a first member extending in a first direction and a second armextending in another direction; and wherein said first arm is adapted tobe inserted between and guided through the space between the first andthe second spinous processes so that the implant can be positioned withone member on one side of the spinous processes and the second member onthe other side of the spinous processes.
 66. The implant of claim 65wherein: said first and second members are flexible.
 67. A method ofrelieving pain due to the development of spinal stenosis and the like inthe spinal column including the steps of: accessing adjacent first andsecond spinous processes of the spinal column from one side; position aZ-shaped implant between the spinous processes in order to eitherdistract and maintain the distraction between the spinous processesand/or to maintain a distraction between the two spinous processes;wherein said Z-shaped implant has first and second members extendingfrom a central body, and the positioning step includes guiding the firstarm between a space between the first and second spinous processes untilthe central body is located between the spinous processes with the firstarm on one side of the spinous processes and the second arm on the otherside of the spinous processes.
 68. The method of claim 67 including thesteps of: selecting arms that are contoured to the spine; andpositioning the arms adjacent to the portion of the spine for which theyare contoured.
 69. The method of claim 67 including the steps of:selecting arms that are contoured to be positioned adjacent to one ofL4-L5 and L5-S1 vertebrae; and positioning the implant between thevertebrae for which the implant was contoured.
 70. The implant of claim1 including: a third means for preventing migration of the implanttoward the lamina of the spinal column.
 71. The implant of claim 8including: said device includes a lamina migration inhibitor.
 72. Animplant for relieving pain associated with the spinal column comprising:a central body a first arm extending from the central body; a second armreceived in a first position in the central body and movable betweensaid first position and a second position extending from the centralbody in order so that the first and the second arms can retain theimplant relative to first and second spinous processes of the spinalcolumn.
 73. The implant of claim 72 wherein: said first and second armsare located on opposite sides of the spinous processes when implantedand said arms extend in opposite directions with the second arm extendedfrom the central body.
 74. The implant of claim 72 including: a thirdarm received in a first position in the central body and movable betweensaid first position and a second position extending from the centralbody.
 75. The implant of claim 72 wherein: said first arm is aperipheral flange extending from and about the central body.
 76. Animplant for flattening the spine in order to increase the volume of atleast one of the spinal canal and the neural foramen comprising: acentral body with first and second saddles which are adapted to receiveadjacent spinous processes; first and second arms projecting from thefirst saddle and third and fourth arms projecting from the secondsaddle; said first and fourth arms are longer than the central body withthe first arm being longer than the fourth arm; and the second and thirdarms are about the length of the central body and/or shorter than thecentral body with the second arm being shorter than the third arm. 77.The implant of claim 76 wherein: said third arm is below said first armand said fourth arm is below said second arm.
 78. The implant of claim76 wherein: said third arm is substantially shorter than the first armso that the implant can be directed between the space between adjacentspinous processes with the first arm first urged through the space andthe spinous processes distracted so that the third arm can be urgedthrough the space with the central body positioned between the spinousprocesses.
 79. The implant of claim 76 wherein: said first arm is slopedin a direction away from the central body in order to accommodate theshape of a vertebra.
 80. The implant of clam 76 wherein: said first,third, and fourth arms are sloped in a direction away from the centralbody in order to accommodate the shape a vertebra.
 81. The implant ofclaim 76 wherein: said central body includes a bore therein.
 82. Theimplant of claim 76 wherein: said central body includes a bore thereinso that the implant has a modulus of elasticity that is compatible withthat of bone.
 83. The implant of claim 76 wherein: at least one of saidsaddles is sloped in order to accommodate a vertebra.
 84. The implant ofclaim 76 wherein: at least one of said saddles is sloped aboutapproximately 30° so as to accommodate a vertebra.
 85. The implant ofclaim 76 wherein: at least one of said arms is sloped aboutapproximately 30° so as to accommodate a vertebra.
 86. The implant ofclaim 76 wherein: said first arm has a sloped portion which is sloped ina direction away from the central body; and said first arm has a recesslocated at a distal end of said sloped portion followed by a convexportion in order to accommodate the shape of a vertebra.
 87. The implantof claim 76 wherein: said implant has a modulus of elasticity which iscompatible with bone.
 88. The implant of claim 76 wherein: said implanthas as modulus of elasticity which is approximately about twice that ofbone.
 89. An implant for flattening the spine in order to increase thevolume of at least one of the spinal canal and the neural foramencomprising: a central body with first and second saddles which areadapted to receive adjacent spinous processes; first and second armsprojecting from the first saddle and third and fourth arms projectingfrom the second saddle; said first and fourth arms are longer than thesecond and third arms; and said third arm is located below said firstarm and said fourth arm is located below said second arm, with saidfourth arm located diametrically opposite said first arm in order tofacilitate the implantation of the implant between adjacent spinousprocesses.